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ACTIVE NOT RECRUITING
NCT04251806

Sleep-disordered Breathing in Infants With Myelomeningocele

Sponsor: University of Michigan

View on ClinicalTrials.gov

Summary

This study aims to determine whether the risk for sleep-disordered breathing in infants with myelomeningocele (a severe form of spina bifida) differs among those who underwent fetal vs. postnatal surgery, and to examine the link between sleep-disordered breathing and neurodevelopment.

Key Details

Gender

All

Age Range

Any - 2 Years

Study Type

OBSERVATIONAL

Enrollment

173

Start Date

2020-07-21

Completion Date

2026-07

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

neonatal polysomnography

This procedure will allow the detection of sleep-disordered breathing in the neonatal period.

DIAGNOSTIC_TEST

2-year Bayley Exam

This procedure will evaluate neurodevelopmental outcomes.

DIAGNOSTIC_TEST

2-year polysomnography

This procedure will allow the detection of sleep-disordered breathing at 2 years of age.

Locations (9)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Mott Children's Hospital

Ann Arbor, Michigan, United States

Children's Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University of Texas-Houston

Houston, Texas, United States